MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-18 for LIGHT FANTASTIC II TRACK MOUNTED DENTAL LIGHT HBT LFTII manufactured by Pelton & Crane.
[53454167]
Upon evaluations by the local pelton & crane distributor it was determined the roll pins were not installed by the distributor during installation/servicing. The roll pins will prevent the light from unscrewing from the trolley after installation. The dental light was manufactured over 36 years ago and is past the expected life of the device.
Patient Sequence No: 1, Text Type: N, H10
[53454168]
A dental professional was moving the tracklight when the light came apart from the trolley and fell down into the dental chair. There was no patient in the room at the time of event. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017522-2016-00020 |
| MDR Report Key | 5886601 |
| Date Received | 2016-08-18 |
| Date of Report | 2016-07-22 |
| Date of Event | 2016-07-21 |
| Date Mfgr Received | 2016-07-22 |
| Device Manufacturer Date | 1980-07-01 |
| Date Added to Maude | 2016-08-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. FRANK RAY |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal | 28273 |
| Manufacturer Phone | 7045877227 |
| Manufacturer G1 | PELTON & CRANE |
| Manufacturer Street | 11727 FRUEHAUF DRIVE |
| Manufacturer City | CHARLOTTE NC 28273 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28273 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIGHT FANTASTIC II TRACK MOUNTED DENTAL LIGHT |
| Generic Name | DENTAL LIGHT |
| Product Code | EAZ |
| Date Received | 2016-08-18 |
| Model Number | HBT |
| Catalog Number | LFTII |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PELTON & CRANE |
| Manufacturer Address | 11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US 28273 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-18 |